The goal of this feasibility randomized controlled trial is to investigate the applicability of software that aims to improve symptoms of frailty by implementing customized interventions such as physical exercise and cognitive training implemented through a mobile app for 16 weeks for patients diagnosed with frailty or prefrailty. The primary outcomes are adherence, retention rates, and recruitment rates. Participants will participate in customized interventions including physical exercise, cognitive training, nutritional guidance, and management of disease related to frailty for 16 weeks.
The physical exercise program will comprise aerobic exercise, balance-improving exercises, flexibility-enhancing activities, and strength-building exercises targeting major muscle groups through a mobile app . Customized cognitive training, performed using a mobile app, targets the cognitive domains of prospective memory and executive function. Nutritional intervention will be performed to treat frailty symptoms and disease related to frailty through a mobile app. Education and management of disease related to frailty will be done through a mobile app.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
For 16 weeks, participants will receive exercise, cognitive training, nutrition education, and disease education through a smartphone app, and the content and intensity of the intervention will be adjusted every four weeks through an assessment of frailty symptoms through the app.
Inha University Hospital
Incheon, South Korea
RECRUITINGEwha Womans University Seoul hospital
Seoul, South Korea
NOT_YET_RECRUITINGAjou University Hospital
Suwon, South Korea
NOT_YET_RECRUITINGretention rate
retention rate ≥ 70%
Time frame: From enrollment to the end of intervention at 16 weeks
Adherence to the protocol
Adherence to the protocol ≥ 70%
Time frame: From enrollment to the end of intervention at 16 weeks
recruitment rate
recruitment rate ≥ 50%.
Time frame: From enrollment to the end of intervention at 16 weeks
Change from Baseline in Korean Frailty Index for Primary Care at 16 weeks
The score ranges from 0 to 1. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Modified Fried frailty phenotype score at 16 weeks
The score ranges from 0 to 5. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Lubben Social Network Scale at 16 weeks
The score ranges from 0 to 50. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in 14-item cognitive subscale of the Alzheimer's Disease Assessment Scale at 16 weeks
The score ranges from 0 to 90. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Korean Mini-Mental State Examination-2 at 16 weeks
The score ranges from 0 to 30. A higher score indicates better performance.
Time frame: From enrollment to the end of intervention at 16 weeks
Change from Baseline in Clinical Dementia Rating scale-Sum of Boxes at 16 weeks
The score ranges from 0 to 18. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Korean Instrumental Activities of Daily Living at 16 weeks
The score ranges from 0 to 3. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Modified Barthel Index: at 16 weeks
The score ranges from 0 to 100. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Center for Epidemiological Studies-Depression Scale at 16 weeks
The score ranges from 0 to 60. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Quality of life-Alzheimer's disease at 16 weeks
The score ranges from 0 to 52. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in gait speed at 16 weeks
A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Short Physical Performance Battery at 16 weeks
The score ranges from 0 to 12. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline inTimed Up and Go test at 16 weeks
A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in 30 s sit-to-stand at 16 weeks
A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in 2 min stepping test at 16 weeks
A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Mini Nutritional Assessment at 16 weeks
The score ranges from 0 to 14. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in Nutritional Quotient for Elderly at 16 weeks
The score ranges from 0 to 100. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from Baseline in skeletal muscle mass at 16 weeks
A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Number of Participants with Treatment-Related Adverse Events
A lower score indicates better performance.
Time frame: From enrollment to the end of intervention at 16 weeks
Change from baseline in MIND diet checklist at 16 weeks
The score ranges from 0 to 15. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in International Physical Activity Questionnaire-Short Form at 16 weeks
The score ranges from 0 to 20,000. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in LDL-C at 16 weeks
The score ranges from 0 to 300. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in HDL-C at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in HbA1c at 16 weeks
The score ranges from 0 to 30. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in eGFR at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in blood pressure at 16 weeks
The score ranges from 0 to 250. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in body weight at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance in frailty.
Time frame: From baseline to the end of intervention at 16 weeks
Change from baseline in waist circumference at 16 weeks
The score ranges from 0 to 200. A higher score indicates better performance in frailty.
Time frame: From baseline to the end of intervention at 16 weeks
Occurrence of aging-related diseases
The score ranges from 0 to 10. A lower score indicates better performance.
Time frame: From baseline to the end of intervention at 16 weeks
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